The invention relates to an auditory ossicle prosthesis which replaces or spans at least one member or parts of one member of the ossicular chain, wherein the auditory ossicle prosthesis comprises, at one end, a substantially plate-shaped first securing element for bearing on the tympanic membrane or on the footplate of the stirrup, and, at its other end, a second securing element for mechanical connection to a member or parts of a member of the ossicular chain or to the inner ear, and also a connection element that connects the two securing elements to each other so as to conduct sound, and wherein the plate-shaped first securing element has a radially inner coupling area for mechanically coupling the first securing element to the connection element and also a plurality of web elements for radial connection of the radially inner coupling area to radially outer portions of the first securing element.
A device of this kind is known from DE 10 2007 013 708 B3.
Auditory ossicle prostheses are used to transmit sound or a sound signal from the tympanic membrane to the inner ear when the ossicles of the human middle ear are entirely or partially absent or damaged. The auditory ossicle prosthesis has two ends, and, depending on the specific circumstances, one end of the auditory ossicle prosthesis is secured to the tympanic membrane, for example by means of a headplate, and the other end of the auditory ossicle prosthesis is secured, for example, to the stirrup of the human ossicular chain or plunged directly into the inner ear. With the known auditory ossicle prostheses, the sound conduction or signal transmission between the tympanic membrane and the inner ear is often made possible only to a limited extent, since these prostheses are able only to an extremely limited extent to replace the natural anatomical features of the ossicular chain.
After the prosthesis has been placed surgically in the middle ear and the tympanic membrane has been closed again, the so-called incorporation phase starts. During this period, scars and tissue strands form and generate unpredictable forces, which can lead to the prosthesis shifting from its local position. In the case of a stiff connection between headplate and shaft, increased pressure peaks can occur between the edge of the headplate and the tympanic membrane or the transplant between tympanic membrane and headplate. These pressure peaks can be so high as to result in penetration or extrusion through the tympanic membrane. For this reason, it is very useful if, after the operation, the prosthesis has a certain degree of mobility and flexibility, such that the headplate is able to automatically adapt itself to the position of the tympanic membrane after the operation.
Since the anatomical features of the ear, for example the position, shape and size of the stirrup, anvil, hammer and tympanic membrane, also vary between individuals, it is very advantageous if auditory ossicle prostheses are not made rigid, but instead have a certain flexibility or variability.
To achieve this flexibility or variability, various securing and coupling devices for auditory ossicles are known that have elastic parts and/or hinges. Such a hinged connection between a securing element, mounted on the footplate of the stirrup, and the elongate shaft is described in EP 1 181 907 B1 and is offered by the Applicant under the brand name “Ball-Joint”.
Another complication that occurs occasionally is the result of insufficient air in the middle ear cavity and of associated acute or chronic inflammations, tumor formations, adhesions in the region of the tympanic membrane and stiffening of the latter. In cases of dysfunction of the Eustachian tube, for example, an underpressure may develop in the middle ear and cause eversion or so-called retraction of the tympanic membrane, with resulting adhesion to the stirrup, for example. To counteract this and to be able to follow the postoperative movements of the tympanic membrane, the headplates in known auditory ossicle prostheses are designed to be able to tilt relative to the connection element that connects the headplate to the second securing element and that is in most cases designed as an elongate shaft. A headplate of this kind, which is inherently rigid but is able to tilt relative to the connection element, is described inter alia in US 2004/0162614 A1, in the article by M. W. Yung, Ph.D, F.R.C.S, D.L.O. and C. Brewis, F.R.C.S. entitled “A comparison of the user-friendliness of hydroxyapatite and titanium ossicular prostheses” in the Journal of Laryngology & Otology, February 2002, volume 116, pages 97-102, or, for example, also in US 2006/0271190 A1.
However, a disadvantage of these known auditory ossicle prostheses is that, in the event of local medial movements of the tympanic membrane, the inherently rigid tilting of the headplate means that the opposite side of the headplate is also moved out laterally at the same time, as a result of which pressure peaks are generated on the tympanic membrane.
In order to achieve a high level of postoperative flexibility and variability of the prosthesis, while at the same time considerably improving the quality of the sound conduction through the prosthesis, without causing the above-mentioned complications to occur, the aforementioned document DE 10 2007 013 708 B3 proposes that the web elements are of such a geometric configuration that, in the event of local medial movement of the tympanic membrane, they are able to follow this medial movement locally, but do not transmit the movement to remote areas of the headplate. In the event of a slight medial movement of the tympanic membrane, this flexible configuration of the auditory ossicle prosthesis avoids rigid tilting of the whole headplate. Instead, the headplate twists upon itself locally but, in the event of movements of the tympanic membrane caused by sound, it nevertheless transmits these movements to the connection element, such that an optimal transmission of the sound or of the sound signal from the tympanic membrane to the middle ear and onward to the inner ear is ensured.
This provides a very considerable improvement over the rest of the known prior art. Unfortunately, however, further problems still persist that cannot be solved by these measures alone:
In the context of a tympanoplasty procedure in the human middle ear, the pathology and anatomy may necessitate very different kinds of structural reconstructions that are specific to each individual patient. Depending on the extent and shape of any parts of the middle ear anatomy that are still present and that are perhaps partially intact, for example the hammer (malleus), the anvil (incus), the stirrup (stapes) or the tympanic membrane, the middle ear prostheses to be implanted need to have a correspondingly large number of different geometries, some of them differing quite considerably in shape and size.
Since, before the start of surgery of the middle ear, it cannot be predicted, or can be predicted only with great difficulty (only roughly if at all, and practically never exactly), how the subsequent reconstruction of the tympanic membrane and of the ossicular chain will turn out in the course of the operation, a very large number of middle ear prostheses with different geometries, shapes and sizes have to be kept ready for each operation that is to be performed, so as to ensure that the surgeon can at all times select the most suitable prosthesis during the operation, that is to say the prosthesis allowing him to deal with the specific case in question. Otherwise, it may not be possible to guarantee optimal treatment.
Another factor is that said problems of adapting the auditory ossicle prosthesis during surgery may occur not only in the area where the first securing element bears on the tympanic membrane, but also in the area of a likewise plate-shaped second securing element which may be required to allow the prosthesis to bear on the footplate of the stirrup. Particularly for the area of a total reconstruction toward the inner ear, a total prosthesis for this purpose normally has a stamp with a standard diameter of 0.8 mm. Surgeons often express the wish that different surface areas could be made available, depending on the intraoperative situation, to be placed onto the footplate of the stirrup. This desire among specialists would be satisfied by provision of an additional securing element which is connected or can be connected to the stamp and which, in terms of the size of its surface, would be able to be varied within wide limits.
If the auditory ossicle prosthesis is not a total prosthesis, and the first securing element is therefore not designed as a headplate for bearing on the tympanic membrane, but instead as a clip for securing the prosthesis on a member of the ossicular chain, the described problems of adaptation occur exclusively at the inner ear end of the auditory ossicle prosthesis.
A further problem is that, throughout the world, extremely different surgical techniques are employed, which postulate different types of reconstructions in the middle ear. These require suitably adapted middle ear prostheses which differ greatly from one another in size and shape and which again have to be kept ready during each operation in order to allow the surgeon to employ what he considers to be the best method in each particular case.